Study for Optimizing Anti-inflammatory Prophylaxis

• Status: Completed
• Trial end date: 2019-12-18
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Line Kessel
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Patients with age-related cataracts

• Older than 18 years

• Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months.

• Capacity to consent

• Scheduled to undergo cataract surgery at the ophthalmic department at Rigshospitalet-Glostrup, Denmark

• The surgeon must be experienced, defined by a minimum of 1000 cataract extractions completed

• Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study

• Informed consent to participation

Exclusion Criteria:

• Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study

• Medical history of epiretinal membrane, retinal vein occlusion, retinal detachment, uveitis, glaucoma, diabetes mellitus, exudative age-related macular degeneration (AMD) or AMD with geographical atrophy

• Significant complications to surgery such as posterior capsule rupture/vitreous loss, choroidal hemorrhage, and dislocated lens material

• Pregnancy

• Fertile women, i.e. women who are not menopausal.

• Women who breastfeed